Back to resultsDrug-drug Interaction of BI 201335 and Microgynon
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
levonorgestrel
Ethinylestradiol
levonorgestrel
BI 201335
Ethinylestradiol
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion criteria:
1. Healthy female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
Sites / Locations
- 1220.56.1 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reference
Test
Arm Description
multiple doses of Microgynon
multiple doses of Microgynon + BI 201335
Outcomes
Primary Outcome Measures
AUCt,ss of Ethinylestradiol
Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol
Cmax,ss of Ethinylestradiol
maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol
C24,ss of Ethinylestradiol
measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol
AUCτ,ss of Levonorgestrel
Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel
Cmax,ss of Levonorgestrel
maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel
C24,ss of Levonorgestrel
measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel
Secondary Outcome Measures
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.
Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Number of Participants With Drug Related Adverse Events
number of participants with investigator-defined drug related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01570244
Brief Title
Drug-drug Interaction of BI 201335 and Microgynon
Official Title
An Open-label, Two-period, Fixed-sequence, Phase I Trial to Evaluate the Effect of Multiple Doses of 240 mg BI 201335 QD on the Multiple-dose Pharmacokinetics of a Combination of Ethinylestradiol and Levonorgestrel in Healthy Premenopausal Female Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
This study will investigate possible effect of multiple oral doses of BI 201335 on the steady state pharmacokinetics of ethinylestradiol and levonogestrel
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference
Arm Type
Experimental
Arm Description
multiple doses of Microgynon
Arm Title
Test
Arm Type
Active Comparator
Arm Description
multiple doses of Microgynon + BI 201335
Intervention Type
Drug
Intervention Name(s)
levonorgestrel
Intervention Description
multiple doses
Intervention Type
Drug
Intervention Name(s)
Ethinylestradiol
Intervention Description
multiple doses
Intervention Type
Drug
Intervention Name(s)
levonorgestrel
Intervention Description
multiple doses
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
multiple doses
Intervention Type
Drug
Intervention Name(s)
Ethinylestradiol
Intervention Description
multiple doses
Primary Outcome Measure Information:
Title
AUCt,ss of Ethinylestradiol
Description
Area under the curve over the dosing interval t under steady state conditions of ethinylestradiol
Time Frame
on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 hours (h) after drug administration
Title
Cmax,ss of Ethinylestradiol
Description
maximum measured concentration over the uniform dosing interval under steady state conditions of ethinylestradiol
Time Frame
on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
Title
C24,ss of Ethinylestradiol
Description
measured concentration of the analyte at the end of dosing interval under steady state conditions of ethinylestradiol
Time Frame
on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
Title
AUCτ,ss of Levonorgestrel
Description
Area under the curve over the dosing interval τ under steady state conditions of levonorgestrel
Time Frame
on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
Title
Cmax,ss of Levonorgestrel
Description
maximum measured concentration over the uniform dosing interval under steady state conditions of levonorgestrel
Time Frame
on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
Title
C24,ss of Levonorgestrel
Description
measured concentration of the analyte at the end of dosing interval under steady state conditions of levonorgestrel
Time Frame
on day 13 of first period and on day 8 of second period 0:00, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00 h after drug administration
Secondary Outcome Measure Information:
Title
Clinical Relevant Abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG.
Description
Clinical relevant abnormalities for Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events.
Time Frame
from drug administration up to 14 days
Title
Number of Participants With Drug Related Adverse Events
Description
number of participants with investigator-defined drug related adverse events
Time Frame
from drug administration up to 14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
1. Healthy female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1220.56.1 Boehringer Ingelheim Investigational Site
City
Biberach
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25385099
Citation
Sabo JP, Lang B, Elgadi M, Huang F. Effect of the hepatitis C virus protease inhibitor faldaprevir on the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel in healthy female volunteers. Antimicrob Agents Chemother. 2015 Jan;59(1):514-9. doi: 10.1128/AAC.03589-14. Epub 2014 Nov 10.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info
Learn more about this trial
Drug-drug Interaction of BI 201335 and Microgynon
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